Effect of Follicle Flushing on Oocyte Fertilization Rate

NCT ID: NCT03353285

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-27

Study Completion Date

2018-06-01

Brief Summary

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The purpose of this study is to investigate the impact of follicular flushing on fertilization rate in women undergoing IVF treatment

Detailed Description

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This will be a prospective observational study on the effect of follicular flushing on fertilization rate in women undergoing IVF treatment.

Oocytes from each woman will be allocated to one of three groups, depending on the aspirate or flush they are recovered from:

Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing) Group II= egg retrieved in the 1st-2nd flush Group III= egg retrieved in the 3rd-5th flush

development and utilization. Pregnancy rates will be reported as a surrogate outcome.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

Group I= egg retrieved in the follicular fluid of the first aspirate (no flushing)

intracytoplasmic sperm injection (ICSI)

Intervention Type PROCEDURE

All eggs will be fertilized by ICSI

Group II

Group II= egg retrieved in the 1st-2nd flush

intracytoplasmic sperm injection (ICSI)

Intervention Type PROCEDURE

All eggs will be fertilized by ICSI

Group III

Group III= egg retrieved in the 3rd-5th flush

intracytoplasmic sperm injection (ICSI)

Intervention Type PROCEDURE

All eggs will be fertilized by ICSI

Interventions

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intracytoplasmic sperm injection (ICSI)

All eggs will be fertilized by ICSI

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Up to 40 years old
* Both ovaries present
* Triggering final oocyte maturation using hCG or GnRH agonist

Exclusion Criteria

* Egg donation
* PGD cases
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tryfon G Lainas, Phd

Role: STUDY_DIRECTOR

Eugonia

Locations

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Eugonia

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Tryfon G Lainas, PhD

Role: CONTACT

00302107236333

George T Lainas, MD

Role: CONTACT

00302107236333

Facility Contacts

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Tryfon Lainas, PhD

Role: primary

00302107236333

References

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von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.

Reference Type BACKGROUND
PMID: 28333185 (View on PubMed)

Franasiak JM. Follicular flushing: time to look elsewhere to improve in vitro fertilisation outcomes? BJOG. 2017 Jul;124(8):1197. doi: 10.1111/1471-0528.14628. No abstract available.

Reference Type BACKGROUND
PMID: 28276189 (View on PubMed)

Roque M, Sampaio M, Geber S. Follicular flushing during oocyte retrieval: a systematic review and meta-analysis. J Assist Reprod Genet. 2012 Nov;29(11):1249-54. doi: 10.1007/s10815-012-9869-9. Epub 2012 Oct 13.

Reference Type BACKGROUND
PMID: 23065177 (View on PubMed)

Other Identifiers

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number of flushes

Identifier Type: -

Identifier Source: org_study_id

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